Oriel (Levocetirizine Dihydrochloride Tablets) is used in the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children aged 6 years and above.

1. Levocetirizine Tablets
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Oriel (Levocetirizine Dihydrochloride Tablets) is
used in the symptomatic treatment of allergic
rhinitis (including persistent allergic rhinitis) and
urticaria in adults and children aged 6 years and
above.

2. Oriel Tablets
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Oriel Tablets are manufactured by
Intas Pharmaceuticals Limited, India.
(Website: www.intaspharma.com)

3. Levocetirizine DihydrochlorideTablets – Brand
Names
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Levocetirizine Dihydrochloride tablets
are available as Xyzal , Oriel, 1-Al,
Airtis, Allrite, Alzene, Histachek,
Glencet, L-Cetrizet, L-Lodizin,
Lecet, Le Zyncet, Levorid, Tancet-L
and Zylera.

4. Active Ingredient
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The active ingredient contained in Oriel tablets
is Levocetirizine Dihydrochloride. Each film
coated Oriel tablet contains 5 mg of
Levocetirizine Dihydrochloride IP.

5. Chemical Structure
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The structure of Levocetirizine Dihydrochloride
is given below:

6. Uses of Oriel Tablets
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Oriel tablets manufactured by Intas
Pharmaceuticals Limited, India are used in
the symptomatic treatment of perennial and
seasonal allergic rhinitis and chronic
idiopathic urticaria.

7. Levocetirizine Dihydrochloride Tablets Dosage
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➢Adults and children 12 years of age and
older: 5 mg once daily in the evening
➢Children 6 to 11 years of age: 2.5 mg once
daily in the evening
➢Renal Impairment Adjust the dose in patients
12 years of age and older with decreased renal
function
The dosage of Oriel tablets (Levocetirizine
Dihydrochloride) is given below:

8. Storage Instructions
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Oriel (Levocetirizine Dihydrochloride
Tablets) have to be stored at controlled
room temperature i.e. from 20°C to 25°C
(68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

9. Oriel Tablets
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Contraindications
Oriel is contraindicated in patients with a
hypersensitivity to Levocetirizine Dihydrochloride
or any other ingredient of this medication.
Patients with severe renal impairment (<10 ml/min
creatinine clearance), and patients undergoing
hemodialysis and children 6 months to 11 years of
age with impaired renal function must not be
administered Oriel Tablets.
Patients with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-
galactose malabsorption must not be administered
this medicine.

10. Warnings
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During clinical trials the occurrence of somnolence, fatigue, and
asthenia has been reported in some patients under therapy with
Levocetirizine. Avoid engaging in hazardous occupations requiring
complete mental alertness such as driving or operating machinery
when undergoing therapy with Oriel tablets.
Avoid concurrent use of alcohol or other central nervous system
depressants with Levocetirizine Dihydrochloride tablets.
The use of the film-coated tablet formulation is not recommended
in children aged less than 6 years since this formulation does not
allow for appropriate dose adaptation.
Urinary retention has been reported post-marketing with
Levocetirizine. Levocetirizine tablets (Oriel) must be used with
caution in patients having predisposing factors of urinary retention
(e.g. spinal cord lesion, prostatic hyperplasia) as Levocetirizine can
increase the risk of urinary retention.

11. Levocetirizine Side Effects
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➢Common Oriel (Levocetirizine Dihydrochloride Tablets)
side effects can include somnolence, headache, fatigue,
nasopharyngitis, dry mouth, and pharyngitis in subjects 12
years of age and older and pyrexia, somnolence, cough, and
epistaxis in children 6 to 12 years of age.
➢ Further uncommon incidences of adverse reactions like
asthenia or abdominal pain and urinary retention were
observed. Additional side effects of medical significance
observed at a higher incidence than in placebo in adults and
adolescents aged 12 years and older exposed to
Levocetirizine are syncope (0.2%) and weight increased
(0.5%).
➢Side effects observed in patients 1 to 5 years of age and in
6 months to 11 months of age were pyrexia, diarrhoea,
vomiting, otitis media, constipation, salivary hypersecretion,
thirst, hunger, fatigue, anorexia, somnolence, psychomotor
hyperactivity, sleep disorder, middle insomnia, epistaxis,
pruritius, headache.

12. Levocetirizine Side Effects
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➢In addition to the adverse reactions reported during clinical
studies and listed above, very rare cases of the following
Levocetirizine side effects have been reported during post-
marketing experience
➢Immune System Disorders: Hypersensitivity including
anaphylaxis
➢Metabolism and Nutrition Disorders: Increased appetite
➢Psychiatric Disorders: Aggression, agitation, hallucinations,
depression, insomnia, suicidal ideation.
➢Nervous System Disorders: Convulsion, paraesthesia,
dizziness, syncope, tremor, dysguesia.
➢Ear and Labyrinth Disorder: Vertigo
➢Eyes Disorders: Visual disturbances, blurred vision
➢Cardiac Disorders: Palpitations, tachycardia
➢Respiratory, Thoracic, and Mediastinal Disorders: Dyspnoea

13. Levocetirizine Side Effects
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➢Gastrointestinal Disorders: Nausea, vomiting,
diarrhoea
➢Hepatobiliary Disorders: Hepatitis
➢Skin and Subcutaneous Tissue Disorders:
Angioneurotic oedema, fixed drug eruption, pruritus,
rash, urticaria
➢Musculoskeletal, Connective Tissues, and Bone
Disorders: Myalgia, Arthralgia
➢Investigations: Weight increased, abnormal liver
function tests
➢Renal and Urinary Disorders: dysuria, urinary
retention
➢General Disorders and Administration Site
Conditions: oedema

14. Levocetirizine Dihydrochloride Overdose
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Symptoms of Levocetirizine
Dihydrochloride overdose can
include drowsiness in adults, and in
children, initially agitation and
restlessness, followed by
drowsiness.

15. Oriel Tablets Overdose
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There is no known specific antidote to
Levocetirizine (Oriel Tablets) . In case
Oriel overdose occurs consider standard
measures to remove any unabsorbed
medicine. Gastric lavage should be
considered following short-term ingestion.
Levocetirizine is not effectively removed by
haemodialysis.

16. Levocetirizine Dihydrochloride During Pregnancy
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Levocetirizine Dihydrochloride (Oriel
tablets) has been classified by the US FDA
as Pregnancy Category B.
There are no adequate and well-controlled
studies of Levocetirizine conducted in
pregnant women. Due to the fact that
animal reproduction studies are not always
predictive of human response, Oriel
tablets (Levocetirizine Dihydrochloride)
should be used during pregnancy only if
clearly required.

17. Oriel Tablets
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Oriel Tablets click here
© Clearsky Pharmacy
Oriel (Levocetirizine Dihydrochloride Tablets)
by Intas Pharmaceuticals Limited, India.